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EC number: 264-776-4 | CAS number: 64325-78-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-06 to 2018-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- adpoted March 2006, corrected July 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Details on sampling
- Substance specific analysis was performed at the test site of menal GmbH.
- Sampling: 4 sampling time points of at each of 2 test concentrations (8 samples).
The sampling was conducted according to the following specification:
- After 0 h, 24 h and 48 h exposure, both additional vessels of NC and A were sampled; one sample per replicate: 2 samples of 5 mL per treatment group.
- After 72 h exposure, both additional vessels and 2 replicates from the test vessels of NC and A were sampled; one sample per replicate: 4 samples of 5 mL per treatment group.
- Concentrations: A (nominal 100 mg/L) and C (control)
- Sampling method: The samples were filled into 10 mL glass vials. To each vial, 5 mL acetonitrile was added and samples were stored in the freezer (≤ -18 °C).
- Sample storage conditions before analysis: For each sampled treatment, one of the analytic samples from 0 h, 24 h, 48 h and 72 h was sent to the analytical laboratory at the test site menal GmbH for chemical analysis. The remaining samples were stored as retain samples at Hydrotox GmbH in the freezer (≤ -18 °C) until finalisation of the study. Samples were stored at -20°C ± 10°C at menal GmbH until analysis, and least until finalization of the phase report after which they will be destroyed or further stored. On assay day, samples were thawed at room temperatures and directly transferred into an HPLC-vial.
- Shipping: Samples were personally handed over between Hydrotox GmbH and menal GmbH. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution was prepared as Water Soluble Fraction by adding 111.2 mg test item to 1000 mL test medium and shaking for 48 hours using an overhead shaker at 21.2 - 23.0 °C in the dark. The Water Soluble Fraction was filtered through a fibre-glass filter with a retaining range up to 0.6 nm, and used as highest test item loading rate in the test. The filter was prepared by rinsing with purified water and preconditioning with ca. 100 mL WSF (which was discarded) to reduce adsorption of the test item.
This filtered stock solution was used as single test item loading rate in the test (limit test).
- Controls: The negative control was the test medium.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata, also known as Raphidocelis subcapitata
- Strain: 61.81 SAG
- Source (laboratory, culture collection): Culture Collection of Algae at the University of Goettingen
- Age of inoculum (at test initiation): 4-day-old pre-culture was used as inoculum in the test
- Method of cultivation: suspension culture
ACCLIMATION
- Acclimation period: Twice a week, the stock suspension is inoculated into fresh Holm-Hansen composition: 496 mg/L NaNO3, 39 mg/L K2HPO4, 75 mg/L MgSO4×7H2O, 36 mg/L CaCl2×2H2O, 58 mg/L Na2CO3, 10 mg/L Na2EDTA×2H2O, 3 mg/L citric acid, 3 mg/L iron citrate, 0.1144 mg/L H3BO3, 0.0724 mg/L MnCl2× 4H2O, 0.0088 mg/L ZnSO4×7H2O, 0.0032 mg/L CuSO4×5H2O, 0.0010 mg/L Na2MoO4×2H2O, 0.0016 mg/L CoCl2×6H2O medium under axenic conditions to keep it in exponential growth.
- Culturing media and conditions (same as test or not): 4 days before test, the same culturing conditions as in the test.
- Any deformed or abnormal cells observed: no abnormality observed - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- Not reported
- Test temperature:
- 22.7 - 23.0°C
- pH:
- 7.5 - 7.8 (control);
7.7 - 7.8 (test item treatment) - Dissolved oxygen:
- Not reported
- Salinity:
- Not reported
- Conductivity:
- Not reported
- Nominal and measured concentrations:
- Nominal loading rate in the test vessel [mg/L]: 0, 100
Measurred geom. mean [mg/L]: 0, 0.220 - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer glass flasks 100 mL
- Type: closed, with cellulose stoppers
- Material, size, headspace, fill volume: test vessels are filled to 50 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): no, static test
- Initial cells density: 7 x 10E4 cells/mL
- Control end cells density: 107.121 x 10E5
- No. of vessels per concentration (replicates): 6 replicates per concentration
- No. of vessels per control (replicates): 6 replicates per negative control
GROWTH MEDIUM
- Standard medium used: yes, OECD TG 201 medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: solutions to make the 10-fold concentrated test medium were dissolved in deionised water; 1-fold concentrated medium was prepared by diluting 10-fold medium with ultrapure water
- Intervals of water quality measurement: The pH was measured at the start and end of the test; vessels were kept in light incubator (21 - 24 °C, constant within ± 2 °C) and continuously illuminated by lateral fluorescent tubes (58 W each), and mean light intensity was reported.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: Mean light intensity was 71.1 µE m-2 s-1 ± 3.8 %, supplied by lateral fluorescent tubes
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : cell density, every 24 h; The inhibition of algal growth was determined from yield and growth rate; calculation according to the OECD guideline 201
- Determination of cell concentrations: To convert the measured surrogate parameter chlorophyll fluorescence into a cell concentration (the measure for biomass), a correlation factor is determined twice a year within the quality check by measuring cell concentrations of different dilutions with the Coulter Counter and the corresponding fluorescence with the microplate fluorescence reader. Chlorophyll fluorescence values are correlated with measured cell concentrations. The slope of the curve gives the conversion factor. By means of the conversion factor, the surrogate parameter chlorophyll fluorescence is converted into a cell concentration
- Chlorophyll measurement: The algal biomass was monitored by measuring the chlorophyll fluorescence after 0 h, 24 h, 48 h and 72 h. From each test vessel, 200 µL test solution was transferred into a 96-well microplate and the fluorescence measured with the fluorescence microplate reader at an excitation wavelength of 465 nm and an emission wavelength of 670 nm. Each measurement was conducted in duplicate. If the variation coefficient was > 10 %, the measurement was repeated. Test medium was measured as blank value and subtracted from the fluorescence values in the test vessels.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: none, limit test
- Range finding study: Yes, a preliminary test without GLP was performed before start of this GLP-study
- Test concentrations (in range finding study): Nominal loading rates of 50, 100 and 200 mg/L test item were tested and resulted in inhibition of 3.8 %, -6.1 % and 3.7 % for growth rate (72 h), respectively.
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an acute toxicity test according to the OECD guideline 201 Pseudokirchneriella subcapitata was exposed to 220 µg/L N-Benzoyl-5'-O-[bis(4 -methoxyphenyl)phenylmethyl]-2'-deoxyadenosine/L (meas., geom. mean; limit of water solubility). No toxic effect on P. subcapitata was observed.
- Executive summary:
In a 72 hour growth inhibition test (limit test), cultures of Pseudokirchneriella subcapitata, Strain No. 61.81 SAG were exposed to N-Benzoyl-5'-O-[bis(4 -methoxyphenyl)phenylmethyl]-2'-deoxyadenosine at nominal concentration 100 mg test item/L (220 µg/L measured, geom. mean) under static conditions in accordance with the OECD guideline 201. The exposure concentration was verified in the analytical part. As the measured test item concentrations are not within ± 20 % of the nominal loading rate, according to OECD 202 (2004) and OECD 23 (2000), all results are given in relation to the analytically measured test item concentrations. The geometric mean of the measured test item concentration represents only 0.2 % of the nominal concentration which can be explained by the water solubility of the test item (i.e. 0.14 mg/L at pH 6.8 and 20 °C in distilled water, see section 4.8 of the present dossier). The limit of water solubility of the test item in test medium was reached. Therefore, N-Benzoyl-5'-O-[bis(4 -methoxyphenyl)phenylmethyl]-2'-deoxyadenosine is not toxic up to the limit of water solubility to P. subcapitata.
No abnormalities were observed.
This toxicity study satisfies the guideline requirements for algae growth inhibition study according to OECD guideline 201.
Results Synopsis
Test Organism: Pseudokirchneriella subcapitata
Test Type (Flowthrough, Static, Static Renewal): Static
Effect levels:
(Lowest/No observed) Effect Concentration (95% Confidence Limits) Measured test item concentration (mg/L) Based on yield (72 hours) Based on growth rate (72 hours) LOEC > 0.220 > 0.220 NOEC ≥ 0.220 ≥ 0.220
Reference
CRITERIA OF VALIDITY
- The biomass (cell concentration) in the control has increased by a factor of 102.0 and therefore ≥ 16 during the test period.
- The mean coefficient of variation for section-by-section growth rate (day 0 - 1, 1 - 2 and 2 - 3) in the control is 10.67 % and therefore ≤ 35 %.
- The coefficient of variation of average specific growth rate during the test period in the control replicates is 1.35 % and therefore ≤ 7 %.
- The test is valid according to OECD Test Guideline 201 (23 March 2006).
Description of key information
The toxicity of N-Benzoyl-5'-O-[bis(4 -methoxyphenyl)phenylmethyl]-2'-deoxyadenosine was assessed in a 72-hr growth inhibition test with Pseudokirchneriella subcapitata according to OECD test guideline 201 and under GLP. No effects were observed up to the limit of water solubility:
NOEC ≥ 220 µg a.i./L (measured)
LOEC > 220 µg a.i./L (measured)
Key value for chemical safety assessment
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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